BEUDAMED
    FDA Enforcement Class II Terminated

    Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000

    Recall: Z-0109-2019 · Reported October 24, 2018

    Enforcement

    Recall Number
    Z-0109-2019
    Event ID
    81009
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Besmed Health Business Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 24, 2018
    Initiation Date
    August 9, 2018
    Classification Date
    October 15, 2018
    Termination Date
    May 10, 2019
    Address
    No.5, Lane 116, Wu-Kong 2nd Road, Wu-Ku District, New Taipei City, N/A, N/A, Taiwan

    Description

    Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000

    Reason

    Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterile

    Code Info

    Lot Numbers: MO0612G40021 and MO0605G40014

    Distribution

    US Nationwide, and country of Canada.

    Quantity

    267 units